510(k) · Cleared
ClearedThe ICHOR Panacea Vascular Embolectomy Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ichor Vascular, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Dec 21, 2018 as substantially equivalent to K171493 (Capture Vascular, Inc., 2017) after a 133-day review. Its family tree reaches back 1 generation to 2017. 2 later devices descend from it.
- Decided
- Dec 21, 2018
- Review
- 133 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K171493 (2017). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK171493 MegaVac Mechanical Thrombectomy SystemCapture Vascular, Inc. · 2017
- This deviceK182167 The ICHOR Panacea Vascular Embolectomy Catheter SystemIchor Vascular, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK233917 ICHOR 7F Embolectomy System (ICH-7F)Ichor · 2024
- Descendant · cites it directly · 0 of its ownK230743 ICHOR 14F Embolectomy SystemIchor · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K171493 | MegaVac Mechanical Thrombectomy System | Capture Vascular, Inc. | 2017 | — |
| 0 (this device) | K182167 | The ICHOR Panacea Vascular Embolectomy Catheter System | Ichor Vascular, Inc. | 2018 | — |
| +1 | K233917 | ICHOR 7F Embolectomy System (ICH-7F) | Ichor | 2024 | — |
| +1 | K230743 | ICHOR 14F Embolectomy System | Ichor | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEW device
- #1 K213402 Triever24, Triever20score 28.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171493 | MegaVac Mechanical Thrombectomy SystemSummary page 4…hrombi. The devices are provided sterile, non-pyrogenic, and intended for single use only. Predicate Device: MegaVac (K171493) Reference Devices: Fogarty Occlusion Catheter (K152762) Penumbra Embolectomy Aspiration System (K160… | 2017 |
| † | K152762 | Fogarty Occlusion Catheter | 2015 |
| † | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
The Panacea embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels.
The device is intended for the peripheral vasculature, and is not intended for use in the coronary or neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182167: The ICHOR Panacea Vascular Embolectomy Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182167
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026